About this trial
In this project, we will develop a unique OCT-Raman system based on a selective sampling approach optimised for high-resolution analysis of whole lumpectomy specimens. The aim of using OCT is not to detect the cancer but to identify the adipose tissue, such that the large adipose tissue regions are excluded from any further measurements by Raman spectroscopy.
While OCT has a limited ability to distinguish between tumour and surrounding normal stroma, adipose tissue has a distinctive appearance in the OCT images due to low backscattering within adipose cells (filled with lipids and small/flattened nuclei) compared to the highly scattering benign dense tissue (stroma, ducts and lobules) and malignant tissue. Such specific patterns allow identification of normal adipose tissue from breast tissue (classification models based on reflectivity profiles) with 94% sensitivity and 93% specificity. This will reduce the task of Raman measurements, which can be focused on the smaller remaining regions to discriminate between the benign and malignant tissue. This flexible and adaptable scanning strategy will achieve a much-improved diagnosis accuracy and speed to cover all surgical margins within practical timescales.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing breast surgery (wide local excision).
Able to give informed consent.
Any age.
Disqualifiers
None
Trial population
Patients undergoing WLE in the breast cancer institute
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
OCT-Raman
Diagnostic testa machine to detect positive margins in lumpectomy specimens
Treatment groups
Trial outcomes
Primary outcomes
Design and build a unique OCT-Raman system with integrated machine learning
The primary endpoint is to design the instrument and overall architecture (hardware/software). This includes basic machine learning algorithms for the OCT and OCT-Raman combination. In addition, to install the primary first OCT prototype in UON and test it on lumpectomy and or mastectomy specimen to identify residual cancer cellscancer from normal tissue
Sponsors and contacts
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